Dear Members,

I wish to inform you that SMTA Office bearers & Executive Body Members are planning to visit the FDA Bhawan near Mata Sundari College on 29th September 2022 at 1.30 PM to show solidarity amongst all and request for a meeting with the DCGI Mr Somani and ask status of the notifications especially implementation of GSR 104.*which is the registration system for traders instead of drug license.

I would suggest that all of us should also join SMTA executive team together today and show solidarity.

We all should stand together in this hour of need and show solidarity and our strength. I would request all SMTA Members to come to FDA Bhawan by 1.30 pm today 29/09/2022 and join.

Requesting your maximum presence to Galvanise our efforts to bring in simple registration system instead of licensing .

Thanks & Regards,
Puneet Bhasin
Vice President
SMTA

MINISTRY OF HEALTH AND FAMLY WELFARE
(Department of Health)
NOTIFICATION
New Delhi, the 25th February 1997

G.S.R. 91 (E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published as required by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), at pages 3 and 4 in the Gazette of India, Extraordinary Part II, Section 3, Sub-section (i) dated the 11th January 1996 under the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health) No. GSR 23 (E) dated the 11th January, 1996 inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of sixty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;
And whereas copies of the said Gazette were made available to the public on the 29-1-96; And whereas objections and suggestions received from the public on the said draft rules have been considered by the Central Government.

Date: 20th September, 2022

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)

NOTIFICATION
New Delhi, the 20th September, 2022

G.S.R. 710(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public; Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government; Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in

Date: 9th September, 2022

Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi

File No. 29/Misc./03/2022-DC (228)

Subject: Classification of non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures under the provisions of Medical Devices Rules, 20’17-Reg.

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, sale and distribution, clinical investigation, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which is already implemented from 01.01.2018